Risk Classification of Observations to Donor Semen Establishments (GUI-0053) - Summary

The Risk Classification of Observations to Donor Semen Establishments (GUI-0053) is an administrative tool and is intended to:

• Assist in the classification of observations noted during inspections of semen establishments.
• Promote uniformity in the assignment of ratings to individual observations, and to overall inspection ratings of the semen establishments.
• Provide examples of situations of non-compliance with the Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations).

Health Canada conducts inspections of semen establishments under the authority of section 23 of the  Food and Drugs Act. Inspections are an important component of the national compliance and enforcement program for donor semen. The semen inspection program applies to all known Canadian semen establishments that process, import and/or distribute donor semen used in assisted conception.  For more information on the inspection program please consult policy POL-0023 Inspection Strategy for Semen Establishments.

During an inspection, inspectors assess compliance of semen establishments against the Semen Regulations, including the referenced sections of the Health Canada Directive: Technical Requirements for Therapeutic Donor Insemination.

For a complete copy of the GUI-0053, please contact the Blood, Tissues, Organs and Xenografts Unit.